FRANKFURT: Nine leading US and European vaccine developers pledged on Tuesday to uphold the scientific standards their experimental immunizations will be held against in the global race to contain the coronavirus pandemic.
The companies, including Pfizer, GlaxoSmithKline and AstraZeneca, issued what they called a “historic pledge” after a rise in concern that safety and efficacy standards might slip in the rush to find a vaccine.
The companies said in a statement they would “uphold the integrity of the scientific process as they work toward potential global regulatory filings and approvals of the first COVID-19 vaccines.”
The other signatories were Johnson & Johnson, Merck & Co, Moderna, Novavax, Sanofi and BioNTech.
The promise to play by established rules underlines a highly politicized debate over what action is needed to rein in COVID-19 quickly and to jumpstart global business and trade.
The head of the US Food and Drug Administration (FDA) said last month COVID-19 vaccines may not necessarily need to complete Phase Three clinical trials — large-scale testing intended to demonstrate safety and efficacy — as long as officials are convinced the benefits outweigh the risks.
This prompted a call for caution from the World Health Organization (WHO).
Developers globally have yet to produce large-scale trial data showing actual infections in participants, yet Russia granted approval to a COVID-19 vaccine last month, prompting some Western experts to criticize a lack of testing.
The head of China’s Sinovac Biotech has said most of its employees and their families have already taken an experimental vaccine developed by the Chinese firm under the country’s emergency-use program.
Chinese companies or institutions, which are involved in several leading vaccine projects, did not sign the statement.
“We want it to be known that also in the current situation we are not willing to compromise safety and efficacy,” said co-signatory Ugur Sahin, chief executive of Pfizer’s German partner BioNTech.
“Apart from the pressure and the hope for a vaccine to be available as fast as possible, there is also a lot of uncertainty among people that some development steps may be omitted here.”
BioNTech and Pfizer could unveil pivotal trial data as early as October, potentially placing them at the center of bitter US politics before the Nov. 3 presidential election.
President Donald Trump has said it is possible the United States will have a vaccine before the election. His Democratic rival, Kamala Harris, has said she would not take his word alone on any potential coronavirus vaccine.
The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.
Among other hurdles, approval must be based on large, diverse clinical trials with comparative groups that do not receive the vaccine in question. Participants and those working on the trial must not know which group they belong to, according to the pledge.
BioNTech’s Sahin said there must be statistical certainty of 95%, in some cases higher, and that a positive reading on efficacy does not come just from random variations but reflects the underlying workings of the compound.
The development race has intensified safety concerns about an inoculation, polls have shown.
Western regulators have said they would not cut corners but rather prioritize the review workload and allow for development steps in parallel that would normally be handled consecutively.
Sahin declined to comment on regulators specifically or on what events prompted the joint statement.
The chief executive of German vaccine developer Leukocare, which did not sign the pledge, was more forthright.
“What Russia did — and maybe also there are tendencies in the US to push the approval of a vaccine which has not been sufficiently developed in clinic – bears a huge risk,” said CEO Michael Scholl.
“My biggest fear is that we will approve vaccines that are not safe and that will have a negative impact on the concept of vaccinations in general.”
Leukocare is working with Italy’s ReiThera and Belgium’s Univercells to produce a COVID-19 vaccine currently in phase I testing.
COVID vaccine developers pledge to uphold testing rigour
https://arab.news/vh3e4
COVID vaccine developers pledge to uphold testing rigour
- The pledge was prompted by rising concern that political and economic factors may cause companies to rush vaccine development
- The nine companies said they would follow established guidance from expert regulatory authorities such as the FDA.
Trump takes unconventional approach to communicating to the public about war in Iran
- The communications strategy opened Trump to criticism that he hadn’t done enough to explain the rationale and objectives of the war
Typical of an unconventional presidency, the Trump administration waited more than 48 hours to make any live, public communication to the American people about why it had decided to go to war with Iran.
President Donald Trump discussed why he launched the attack prior to a White House ceremony honoring military heroes on Monday but took no questions from reporters. Earlier in the day, Defense Secretary Pete Hegseth and Joint Chiefs of Staff Chairman Dan Caine briefed journalists at the Pentagon.
The two days previous, Trump delivered two pretaped statements that were released on Truth Social, the social media site owned by the president’s media company, and granted telephone interviews to more than a dozen journalists — several of which produced fragmented responses that, to some, clouded as much as they cleared up.
The communications strategy opened Trump to criticism that he hadn’t done enough to explain the rationale and objectives of the war, even as the American military suffered its first casualties. By contrast, Israeli Prime Minister Benjamin Netanyahu, who has teamed with the US against Iran, delivered two statements the day the war began and addressed reporters Monday at the site of a missile attack that killed nine people. The Israeli military has held multiple press briefings each day.
“The American people need a commander in chief, and he has been absent in that role,” Rahm Emanuel, White House chief of staff under President Barack Obama, said on CNN Monday. Emanuel, a Democrat, is contemplating a run for the presidency in 2028.
An unconventional strategy leads to criticism
Peter Baker, chief White House correspondent for The New York Times, wrote on social media that “after Trump launched a new war on Iran, he did not rush back to the White House to make an Oval Office address to rally the nation as other presidents have done. He stayed at Mar-a-Lago to attend a glitzy political fundraiser.”
That post provoked a response from Steven Cheung, White House communications director. “Imagine being a reporter so consumed with Trump Derangement Syndrome that he wants President Trump to mimic the failed policies of the past. The truth is that President Trump spent the majority of his time monitoring the situation in a secure facility, in constant contact with world leaders, and made multiple addresses to the nation that garnered hundreds of millions of views. He also took dozens of calls with reporters.”
The calls included one with Baker’s colleague at The Times, Zolan Kanno-Youngs. Trump’s mobile phone number is known to many of the reporters who cover him, and the president often takes their calls for on-the-spot interviews. Besides The Times, he spoke in the aftermath of the attack to journalists for ABC, CBS, NBC, CNN, CNBC, Fox News Channel, The Atlantic, The Washington Post, Axios, Politico and an Israeli television station.
Most of the calls were brief and marginally illuminating; Politico’s Dasha Burns said Trump answered but said he was too busy to talk. The public couldn’t hear what Trump said in the interviews and was dependent upon what the journalists chose to report on the conversations.
“I spoke to President Trump today and he told me that the operation in Iran is going to go very fast,” Libby Alon, a reporter for Channel 14 News in Israel, wrote about her interview on X. “It’s doing very well, and (will) make the people of Israel very happy, and the people of the world very happy.”
The Times reported that in its six-minute chat, Trump “offered several seemingly contradictory visions of how power might be transferred to a new government — or even whether the existing Iranian power structure would run that government or be overthrown.”
In one of his two conversations with Trump, ABC News’ Jonathan Karl said when he asked about the death of Iranian Ayatollah Ali Khamenei, the president said: “I got him before he got me. They tried twice. Well I got him first.” CNN’s Jake Tapper went on the air minutes after his conversation Monday, saying Trump told him “the big one is coming soon,” an apparent reference to a future attack.
Asked for comment, White House spokeswoman Anna Kelly said: “President Trump is the most transparent and accessible president in American history. The American people have never had a more direct and authentic relationship with a president of the United States than they have with President Trump.”
Hegseth briefing concentrates on friendly reporters
Pentagon reporters learned late Sunday about Hegseth’s briefing. Reporters from The Associated Press, Reuters, ABC, CBS, NBC, CNN, Fox News Channel and Stars & Stripes were permitted into the briefing room, but Hegseth did not call on them. Instead, he took questions from NewsNation and Trump-friendly outlets like the Daily Caller, Daily Wire, One America News and the Christian Broadcasting Network. Most mainstream news outlets left their regular stations at the Pentagon last fall rather than agree to Hegseth’s rules restricting their work.
Hegseth denounced the “foolishness” of people wanting to know details of the operation in advance, such as whether Americans would commit to more than air power, and said the operation would continue as long as it took to achieve objections. He initially ignored NBC News’ Courtney Kube when she called out a question: “President Trump put a four-week time limit on it. Are you saying he’s wrong?”
Later, Hegseth denounced Kube for asking “the typical NBC sort of gotcha-type question. President Trump has all the latitude in the world to talk about how long it might take — four weeks, two weeks, six weeks, it could move up, it could move back. We’re going to execute at his command the objectives he set out to achieve.”
Unlike Pentagon briefings in past administrations, reporters were given assigned seats, with the Trump-friendly outlets seated in front. Jennifer Griffin, Hegseth’s former colleague at Fox News Channel who left the Pentagon with other reporters after not accepting his new rules, was seated in the last row.
